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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
With a market size of about $30 billion, Japan is the third largest medical device market in the world, however, it is not an easy market to enter. Learn strategies for determining the best regulatory path for your product and investigating market access in this 90-minute live webcast. The presentation will help you better determine the best regulatory registration and reimbursement strategies, required steps, and documentation needed to enter the Japanese medical device market. The program will also cover:
11 November 2022 – 23 December 2022: Early Bird $150 Member | $175 Nonmember 24 December 2022 – 24 January 2023: Regular $175 member | $200 Nonmember
This virtual program will answer questions including:
Regulatory Affairs Professionals
Speakers:
Ames GrossPresident and Founder, Pacific Bridge Medical
Mr. Gross founded Pacific Bridge Medical in 1988 and has helped hundreds of medical companies with regulatory issues and business development in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. In 2008, Medical Device and Diagnostic Industry (MD&DI) magazine named Mr. Gross one of the top 100 executives in the medical business. Mr. Gross is a frequent contributor of articles on Asian medical issues for RAPS, Clinica (England), MD&DI (Los Angeles), and other medically-oriented journals. He has been a featured speaker on the Asian medical markets at the Medical Design and Manufacturing (MD&M) shows, the Medtrade Home Health Care Exhibition, the Regulatory Affairs Professional Society’s annual and regional meetings, and a variety of other medically oriented meetings and conferences. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone.
To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-helpFor account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.